IBSA is a multinational pharmaceutical company headquartered in Lugano, Switzerland, covering several therapeutic sectors, ranging from dermo-esthetics and cardiometabolic products, and has grown significantly in recent years in terms of global market share.
We launched the SAP S/4 HANA transformation program as part of the digital transformation IBSA is pursuing. The objective of the SAP program is to integrate all functional areas into one and the same modern ERP – from production and logistics to sales and administration – in order to support organizational and economic growth.
In this context, BCG Platinion helped IBSA define the strategy and direction of the program at a global level and provided continuous support as a control tower to ensure the achievement of the established objectives. The program started from scratch and became operational for the first time in just eight months.
In addition, the program was awarded the SAP QUALITY AWARD 2022 as the best SAP digital transformation of the year, as it has led to a standardization of the way of working within the group and to greater optimization and efficiency of processes.
We spoke with Giuseppe Bungaro, Group Head of IT, about implementing a hybrid and agile ERP system at IBSA.
What challenges did you face during the SAP transformation in a strictly regulated environment like the pharmaceutical industry? What strategy have you defined together with BCG Platinion?
There were four main challenges that we successfully overcame during our SAP transformation journey:
- The strong will to harmonize processes and the application landscape across the different IBSA industries. We achieved this by implementing the IBSA Global Template!
- A company-wide commitment to get the first trial up and running in a short period of time to optimize the overall investment and avoid a never-ending project. We got our first IBSA Global Template up and running in just eight months!
- Willingness to demonstrate to the regulatory authorities the quality of the final product in accordance with specific requirements of the pharmaceutical industry, such as the Good Practice Rule book. This is a great result considering the complexity of management in line with the overall program.
- Finally, the ability to manage the highly complex program virtually, which was necessary due to the constraints imposed by the pandemic. This was no small task, considering that more than 150 people were involved during the project phase, more than 20 third-party suppliers had to be integrated into the process, and ten production sites, warehouses and the like had to be taken into account.
This complexity was mastered by the strong alliance of IBSA’s IT group and BCG Platinion.
BCG Platinion’s role was crucial in acting as a control tower for the entire program. This meant not only program governance, but also new ways of working such as hybrid or agile methodologies, quality assurance, and design authority that allowed us to ensure scope management against customization and budget increases.
How was the program organized to achieve the ambitious objectives of the SAP transformation given the demanding schedule? How could the schedule be reconciled with validation activities and investment value?
We decided to achieve our objectives by planning the overall implementation with a hybrid agile approach that leveraged leading methodologies such as SAP Activate – supported by the project management model proposed by our systems integrator and in synergistic combination with BCG Platinion’s control tower governance model.
One of the key project guidelines we established was to maximize the usage of standard solutions and limit specific personalization to such of real value. We also decided to use the system integrator’s preconfigured framework as an accelerator, which, together with BCG Platinion’s structured program, allowed us to speed up the exploration phase. This approach created the foundation to meet the primary regulatory requirements of the pharmaceutical industry, in addition to production and quality control requirements.
How did BCG Platinion help stakeholders adopt the program’s „hybrid agile“ governance model?
To tackle such a large and complex implementation that has cross-functional consequences for the entire company, BCG Platinion took a structured approach to project organization and work practices.
As mentioned earlier, we decided to structure the project with a „hybrid agile“ way of working, based on four basic principles that must be strictly adhered to by all participants:
- Iterative approach with two-week sprints organized by correct operations and/or processes and prioritized according to the criticality of the affected processes, which of course facilitated analysis
- Cross-functional collaboration, where stakeholders from different functional areas work together to foster knowledge sharing between functions, improve interaction, and define structured requirements
- Time-boxed approach, with early planning of timeframes for work on the project to encourage involvement of those resources that needed to be pulled away from day-to-day activities
- Objective orientation, which made it possible to focus on Minimum Viable Products (MVPs) to be presented at the end of each sprint
This approach allowed us to easily integrate the validation lifecycle into the project, as suggested by the GAMP 5 policies. These use an agile methodology for validating computer systems in a pharmaceutical environment.
What performance metrics can be used to measure the success of the control tower provided by BCG Platinion for the SAP program?
The project-specific success indicators were formalized at the very beginning of the project. The key defined KPIs to be applied to all go-live events were as follows:
- Scope adherence: Ensure alignment with the mandatory requirements defined in the original business blueprint
- Quality adherence: Ensure business continuity without blocking errors after go-live
- Standard adherence: Adoption of the SAP standard and limitation of adjustments to those needed for compliance with legal requirements and special features of the pharmaceutical business not fully covered by SAP
- Go-live schedule, based on implementation time to be considered between the explore and go-live phases, to monitor investment value and limit any costs for additional time required. The final duration was nine months to go-live, plus four months for complete roll-out in the first branch.
There were also additional elements that needed to be overseen, such as integration with more than 15 external workflows and the system go-live plan, especially the individual propaedeutic tasks to launch the new ERP.
How would you evaluate the introduction of digital technologies in an industrial context like IBSA’s?
Using IBSA as an example, I would say that the introduction of digital technologies is central to the success of the company and is closely linked to the products we manufacture. In my opinion, the integration of our medications with the software we use is so close that the quality of the final product is directly related to the quality of our digital tools.
Robust and stable software therefore ensures a higher quality product to sell to our customers. Digitalization is not a simple IT-to-IT topic, but it is so integrated into operational processes such as production or quality that software validation is closely linked to the quality of the goods we produce and sell. IBSA’s main priority has always been the excellence of its products, and as technology becomes more and more of an enabler for the company, it is becoming more and more important for our company to deliver ever higher product quality.
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Exploiting the potential in strictly regulated industries